Change Management For Software as a Medical Device (IEC 62034 Compliance)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 Creating a new release
01:45 Changing a software requirement
03:17 Creating a new software requirement
04:11 Creating a change request
07:58 Significant changes (MDCG 2020-3)
13:05 How to do this without Formwork (templates)
Your software as a medical device is released and you're IEC 62304 compliant - cool! What now? Now you have to track all changes to your software and document them, too (great). They IEC 62304 calls this "change management". It's very fun. We'll be doing it today.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:45 Changing a software requirement
03:17 Creating a new software requirement
04:11 Creating a change request
07:58 Significant changes (MDCG 2020-3)
13:05 How to do this without Formwork (templates)
Your software as a medical device is released and you're IEC 62304 compliant - cool! What now? Now you have to track all changes to your software and document them, too (great). They IEC 62304 calls this "change management". It's very fun. We'll be doing it today.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
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I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
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